- University of Utah (Salt Lake City, UT)
- … Clinical Practices, FDA , HIPPA ICH , and IRB regulations and regulatory compliance . + Must be a self-starter with exceptional organizational skills, ability ... annual renewal of IRBs, including preparation of all necessary regulatory documents related to the study protocol. 2. Oversees...Good Clinical Practices ( GCP ), and clinical research standard operating procedures to ensure compliance… more
- University of Rochester (Rochester, NY)
- …managers and staff, fostering a collaborative, high-performance culture. + Monitor compliance with program guidelines, deadlines, and regulatory requirements, ... for new staff across multiple institutions, working closely with human resources, regulatory , and compliance teams to streamline efforts. + Proactively update… more
- University of Pennsylvania (Philadelphia, PA)
- …supervision , the regulatory aspects of the initiation of Phase I-V clinical trials with a focus on required regulatory start-up approvals and associated ... regulatory documentation through the IRB, FDA and all applicable institutional regulatory review committees. In collaboration with clinical research teams and… more
- Bristol Myers Squibb (Cambridge, MA)
- …of clinical trials and will supervise and have accountability for the clinical components of regulatory filings + Will contribute to overall strategy for ... a clinical development leader; with greater than 10 years of extensive clinical trial, drug development, and regulatory experience, in addition to a strong… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …simulation approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with ... regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions....external partners. + Maintains a high standard for good clinical practice, compliance , and ethics. + Provides… more
- Sanofi Group (Cambridge, MA)
- …with the global project team and internal partners, such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, ... digital methodologies + Pro-actively progress study execution + Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines… more
- J&J Family of Companies (Titusville, NJ)
- …regulatory affairs, finance, legal, quality assurance, quality monitoring & compliance , clinical supplies unit, data management, medical writing, ... products including Excel and Word + Experience and knowledge of Good Clinical Practices and regulatory requirements for the conduct of clinical trials and… more
- Takeda Pharmaceuticals (Cambridge, MA)
- …simulation approaches (eg, QSP, MBMA) to inform internal decisions and external regulatory interactions. + Represents Clinical Pharmacology in meetings with ... regional regulatory agencies and be responsible for clinical pharmacology summary documents for regulatory submissions....external partners. + Maintains a high standard for good clinical practice, compliance , and ethics. + Mentors… more
- Vanderbilt University Medical Center (Nashville, TN)
- …good clinical practice. Participates in site visits from sponsor, regulatory authorities and others to review research, source documentation, critical documents ... budgets, monitoring efficient invoicing and taking appropriate action to maintain clinical trial billing compliance , providing reports investigators, department… more
- Banner Health (Gilbert, AZ)
- …Master's Degree or advanced certificate degrees preferred. Possession of Clinical Research Coordinator Certification (CRCC). Regulatory knowledge regarding ... to leverage your abilities - apply today. The **RN Clinical Research Specialist** at **Banner MD Anderson Cancer Center...in a safe and ethical manner while ensuring full compliance with FDA and institutional regulations. In this role,… more